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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply from China after a period of disruption caused a shortage of the chelating agent penicillamine.

When supplies of the treatment for the rare genetic disorder Wilson’s disease dried up last year, Chandra Bhagat Pharma and other Indian manufacturers blamed their inability to meet demand on the cessation of API supplies from China. Chandra Bhagat Pharma said the cessation stemmed from the renovation of the API supplier’s facilities. DCGI Dr. GN Singh initially pressured Indian API manufacturer Fleming Laboratories to increase its output, but later changed tack to seek to resolve the blockade in China.

“The matter was taken up with [China Food and Drug Administration] for expediting the inspection of the manufacturer in China, to enable him for exporting to India,” Singh wrote in a public notice about the shortage. “As a result of bilateral consultations the supply of the API was restored.”

By working with CFDA to restore raw material supplies, pressuring local manufacturers of APIs and finished products to increase output and pointing patients toward resources such as Panacea Biotec’s WhatsApp channel, DCGI has contributed to the resolution of the shortage. Singh wants anyone who discovers medicine shortages in the future to tell the Central Drugs Standard Control Organization (CDSCO).

The conditions that created the shortage of penicillamine are still in place in India. Despite talk about increasing local API output as part of the “Made in India” strategy, the country continues to rely on imports from China. Importers undercut the price of Indian manufacturers, resulting in a gradual move away from local sourcing. When only one foreign manufacturer supplies an API, the availability of finished products in India is tied to the activities of a firm outside its jurisdiction.

The Therapeutic Goods Administration (TGA) of Australia is to start publishing the outcomes of its laboratory tests from the middle of this year onward. TGA will provide details of the products it evaluates, its reasons for doing so and whether they passed or failed the test as part of a move to develop a more comprehensive post-market monitoring scheme.

Laboratories currently test approximately 2,000 samples a year for TGA, but very little information about these activities is shared with the public. The Australian government signaled its intent to change its policy on the release of laboratory testing results in September as part of its response to the Expert Review of Medicines and Medical Devices Regulation. That review recommended the development of a more comprehensive post-market monitoring scheme.

To work toward this goal, TGA is to start publishing the product name, ARTG number, sponsor, reason for testing and overall testing result for the product samples it evaluates. Some releases will go beyond this basic information and detail the background to the products, why they were selected for testing and the significance of noncompliant results. For products that fail the evaluation, TGA will provide details of the tests and outcomes of recommended follow-up actions.

TGA plans to publish its first batch of test results in May. This release will cover products tested from May to October 2016. TGA is set to release its second set of test results in November. This batch will feature products tested from November 2016 to April 2017. TGA plans to stick to this schedule in future years.

The delay between testing and publication is intended to give TGA time to investigate and follow-up noncompliant test results. TGA will not publish testing results related to ongoing investigations.

CDSCO Adds Vaccine Filings, EU API Export Requests to Online Portal

India’s CDSCO has unveiled plans to further expand use of its Sugam online regulatory portal. The agency made use of the portal for a range of vaccine-related filings mandatory earlier this month, and is set to do the same for API export clearances and pharmaceutical product certification.

A Sugam module for vaccines went live on 30 January, and its use became mandatory less than one week later. The rollout means companies seeking to test, market, register or import human vaccines must now make their submissions through Sugam. For now, companies must also submit hard copies, a precautionary measure CDSCO has taken previously to prevent technical problems from disrupting regulatory services.

Work on Sugam’s expansion into the other areas discussed by CDSCO this week is less advanced. The regulator plans to put requests for written confirmation of clearance to export APIs to the European Union through the portal from 1 March. CDSCO has set the same deadline for using the portal to process the issuance of certificates of pharmaceutical products (CPPs), a document the national agency and its state-level collaborators jointly give out.

CDSCO used the update on the addition of API export confirmations and CPPs to Sugam to provide details on how the topics fit with its risk-based approach to inspections.

“The Risk Based Inspections will be carried out by the Centre and State with definite tools as reflected in the Risk Based Document prepared by CDSCO. However, the applicants would mandatorily submit the details of observations made during self-inspection and follow any other overseas regulatory bodies or as decided by Central and State Regulator from time to time,” CDSCO’s Arun Sharma wrote.

China Finalizes Rules on Recalling Medical Devices

CFDA has adopted final rules on the recall of medical devices. The text, which is due to come into force on 1 May, is a lightly edited version of the draft guidance CFDA published in September.

Changes to the final version of the guidance include the addition of a paragraph defining “manufacturer” in the context of imported medical devices and a section detailing where online Chinese authorities will publish details of recalls. The final guidance also provides clarity on how long medical device manufacturers must keep records relating to recalls to comply with CFDA’s requirements, and explains which branches of government have the power to order a recall.

Most of the rest of the text has only undergone light editing since the draft guidance was released for consultation in September. That earlier version of the guidance lifted large sections from the original recall text CFDA adopted in 2011. The new version features a broader definition of the types of defects that may necessitate a recall.

The revisions are the latest in a string of changes CFDA has made to the regulation of medical devices. Recalls join quality oversight and adverse event reporting on a growing list of medical device regulatory topics tackled by CFDA in recent years.

More News:

TGA has set out a timeline for consultations on its revisions to drug and medical device regulation. The regulator is planning to tackle more than 15 topics over a six-month period as it seeks to adapt its practices to the findings of the expert review. TGA began the consultation period in October with the release of documents on expedited pathways and international collaboration. TGA Notice